Omnilink Elite 1012623-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179242), received between Dec 16, 2016 and Jan 27, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. ACCESS WAS GAINED VIA RIGHT ILIAC ARTERY AND A 7X19MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (BES) WAS ADVANCED THROUGH THE 6F SHEATH WITH RESISTANCE. THE STENT BECAME DISLODGED FROM THE CATHETER INTO THE RIGHT ILIAC. SEVERAL ATTEMPTS WERE MADE TO CAPTURE THE STENT WITH A 4MM SNARE BUT WERE UNSUCCESSFUL. THE PATIENT WAS TAKEN TO SURGERY, WHERE IT WAS NOTED THAT THERE WAS A DISSECTION AND AN AV FISTULA AS WELL. THE SURGICAL PHYSICIAN MADE A SMALL INCISION, REMOVED THE STENT IN PIECES FROM SUBCUTANEOUS TISSUE AND REPAIRED THE DISSECTION IN THE ARTERY. THE AV FISTULA DID NOT REQUIRE TREATMENT AND REPAIRED ITSELF. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2022. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fistula; Vascular Dissection

  MAUDE report 13367449 ↗
• InjuryJan 21, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE EXTERNAL ILIAC ARTERY. THE 7.0X19MM OMNILINK ELITE STENT WAS DEPLOYED. POST DEPLOYMENT, THE PHYSICIAN FELT HE HAD PLACED THE STENT TOO HIGH AND DECIDED TO PLACE AN UNSPECIFIED BALLOON IN THE DEPLOYED STENT AND PULL DOWN WHICH CAUSED A PERFORATION. THE PERFORATION WAS TREATED USING AN UNSPECIFIED COVERED STENT INSIDE THE OMNILINK STENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9611429 ↗
• InjuryJan 31, 2019Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ILIAC ARTERY. A 7.0X19MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT COMPLETELY FAILED TO INFLATE. DURING REMOVAL OF THE DEVICE THE STENT DISLODGED IN THE ILIAC ARTERY. NO RESISTANCE WAS MET DURING REMOVAL. AS THE STENT HAD DISLODGED PARTIALLY COVERING THE LESION AND PARTIALLY COVERING HEALTHY TISSUE, IT WAS DECIDED TO USE ANOTHER BALLOON TO DILATE THE DISLODGED STENT AND APPOSE IT TO THE VESSEL WALL. THEN ANOTHER STENT WAS USED AND IMPLANTED DISTAL TO THE DISLODGED STENT TO TREAT THE INITIAL LESION LOCATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292845 ↗
• InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD THREE OMNI ELITE AND ONE ABSOLUTE PRO STENTS IMPLANTED IN THE RIGHT COMMON ILIAC AND LEFT COMMON ILIAC ARTERIES ON (B)(6) 2013. APPROXIMATELY A YEAR LATER, THE PATIENT STARTED EXPERIENCING TINGLING AND SEVERE PAIN DOWN BOTH LEGS. MEDICATION HAS BEEN PRESCRIBED. THE PATIENT HAS ALWAYS BEEN SENSITIVE TO METAL; THEREFORE, AN ALLERGY KIT HAS BEEN REQUESTED BY THE ALLERGIST. ADDITIONALLY, THE PATIENT SUFFERS OF AN OCCLUSIVE PERIPHERAL DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Numbness; Pain

  MAUDE report 6182549 ↗